CDSCO approves Abbott's proposal for Protocol Amendment of Triamcinolone Hexacetonide study Dr. Divya Colin20 April 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
Conduct Phase III clinical trial: CDSCO Panel Tells BDR Pharmaceutical on Anti-cancer Drug Abiraterone Acetate Dr. Divya Colin20 April 2024 5:45 PM ISTNew Delhi: Reviewing the justification for waiver of the Phase III clinical trial of the anti-cancer drug Abiraterone Acetate presented by BDR...
Roche Alecensa gets USFDA nod for ALK-positive early-stage lung cancer Ruchika Sharma20 April 2024 12:05 PM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Alecensa (alectinib) for adjuvant treatment following...
Shilpa Medicare marketing partner unveils Pemrydi Rtu in US Ruchika Sharma20 April 2024 11:17 AM ISTPEMRYDI RTU is a novel ready-to-use injection which eliminates the need for refrigeration or reconstitution and dilution for administration to the...
Biocon Limited signs an exclusive licensing and supply agreement for generic Ozempic (Semaglutide) commercialization in Brazil with Biomm S.A. Ruchika Sharma20 April 2024 10:13 AM ISTBiocon, Biomm S.A. ink pact for diabetes drug Semaglutide commercialization in Brazil
Mac-Chem Products Boisar facility Successfully Renews EU GMP Certification Ruchika Sharma19 April 2024 5:38 PM ISTMumbai: Mac-Chem Products (India) Pvt. Ltd. (Mac-Chem) announced today the successful renewal of its European Union Goods Manufacturing...
US FDA calls for USFDA boxed warning changes on CAR-T cancer therapies Kajal Rajput19 April 2024 1:32 PM ISTLondon: The U.S. Food and Drug Administration said on Thursday cancer therapies that use CAR-T technology will require changes to the so-called...
Fresenius Kabi files complaint against Natco Pharma in US over diazepam injection Kajal Rajput19 April 2024 1:29 PM ISTNew Delhi: Natco Pharma on Thursday said a complaint has been filed against it at a district court in the US by Fresenius Kabi over the marketing of...
Reduce PSA level to less than 4 in inclusion criteria: CDSCO Panel Tells Akum Drugs and Pharmaceuticals on FDC Dutasteride plus Silodosin Dr. Divya Colin18 April 2024 6:00 PM ISTNew Delhi: Reviewing the active post-marketing surveillance (PMS) protocol of fixed-dose combination (FDC) Dutasteride plus Silodosin presented by...
USFDA successfully concludes inspection at Piramal Pharma USA facility Ruchika Sharma18 April 2024 5:36 PM ISTMumbai: Piramal Pharma Limited has informed through a recent BSE filing that the US Food and Drug ADministration (US FDA) has issued an...
ChrysCap acquires small stake in generics company La Renon for Rs 600 crore Ruchika Sharma18 April 2024 2:53 PM ISTNew Delhi: Private equity fund ChrysCapital has injected approximately Rs 600 crore ($70 million) into Ahmedabad-based La Renon Healthcare,...
Marksans Pharma gets 5 inspectional observations from USFDA for Goa facility Ruchika Sharma18 April 2024 12:14 PM ISTMumbai: Marksans Pharma has received 5 inspectional observations in Form 483 from the US Food and Drug Administration (USFDA) at...
